Sunovion Announces FDA Acceptance for Review of New Drug Application
for Dasotraline for the Treatment of ADHD

November 10, 2017 10:30 AM Eastern Standard Time

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion
Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food
and Drug Administration (FDA) has accepted for review the New Drug
Application (NDA) for dasotraline, a novel dual-acting dopamine and
norepinephrine reuptake inhibitor (DNRI) being evaluated for the
treatment of attention deficit hyperactivity disorder (ADHD) in
children, adolescents and adults.

The NDA submission is supported by multiple placebo-controlled safety
and efficacy studies, as well as two long-term studies that assessed the
safety of dasotraline in people with ADHD for up to one year. In total,
approximately 2,500 people with ADHD were evaluated in these studies,
and dasotraline was generally well tolerated.

“While there are a number of approved treatments for people living with
ADHD, there remains a significant need for novel therapies that can
address the needs of patients,” said Antony Loebel, M.D., Executive Vice
President and Chief Medical Officer at Sunovion, Head of Global Clinical
Development for Sumitomo Dainippon Pharma Group. “We are pleased that
the FDA has accepted our New Drug Application for dasotraline and look
forward to working closely with the Agency so that we can bring this
important treatment option to people with ADHD.”

About DasotralineDasotraline is a new chemical entity that
acts as a dual dopamine and norepinephrine reuptake inhibitor (DNRI). It
has an extended half-life (47-77 hours) that supports the potential for
stable plasma concentrations yielding a continuous therapeutic effect
over the 24-hour dosing interval.

Dasotraline was discovered by Sunovion Pharmaceuticals Inc. and is
currently in development to evaluate its use in treating attention
deficit hyperactivity disorder (ADHD) and binge eating disorder (BED).
It has not been approved by the U.S. Food and Drug Administration (FDA)
for the treatment of ADHD or BED.

About Attention Deficit Hyperactivity Disorder (ADHD)Attention
deficit hyperactivity disorder (ADHD) is a persistent pattern of
inattention and/or hyperactivity-impulsivity that interferes with
functioning and development, as characterized by inattention (e.g.,
distractibility, forgetfulness) and/or hyperactivity and impulsivity
(e.g., fidgeting, restlessness).1 Approximately 11 percent of
children four to 17 years of age have been diagnosed with ADHD in the
United States.2 Up to 60 percent of children with ADHD
continue to experience symptoms into adulthood.3 It is
estimated that 4.4 percent of adults between ages 18 and 44 years
experience some symptoms and disabilities from ADHD in the U.S.4

In children, ADHD is associated with social rejection and reduced school
performance.5 Children with a history of ADHD are ten times
as likely to have difficulties with friendships and can have more
frequent and severe injuries than peers without ADHD.6 In
adults, symptoms reduce the quality of social or occupational
functioning.5 Studies have shown that ADHD is associated with
higher levels of unemployment, and those who are employed may experience
workplace impairment, reduced productivity and behavioral issues.7
Adults with ADHD are also at increased risk of trauma, workplace
injuries and traffic accidents, are more likely to be diagnosed with
comorbid mental health conditions and have a higher incidence of
separation and divorce.8,9,10

About Sunovion Pharmaceuticals Inc. (Sunovion)Sunovion is a
global biopharmaceutical company focused on the innovative application
of science and medicine to help people with serious medical conditions.
Sunovion’s vision is to lead the way to a healthier world. The company’s
spirit of innovation is driven by the conviction that scientific
excellence paired with meaningful advocacy and relevant education can
improve lives. With patients at the center of everything it does,
Sunovion has charted new paths to life-transforming treatments that
reflect ongoing investments in research and development and an
unwavering commitment to support people with psychiatric, neurological
and respiratory conditions. Sunovion’s track record of discovery,
development and/or commercialization of important therapies has included
Utibron™ Neohaler®
(indacaterol/glycopyrrolate) Inhalation Powder, Seebri™
Neohaler® (glycopyrrolate) Inhalation Powder, Brovana®
(arformoterol tartrate) Inhalation Solution, Latuda®
(lurasidone HCI) and Aptiom® (eslicarbazepine acetate).

Headquartered in Marlborough, Mass., Sunovion is an indirect,
wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion
Pharmaceuticals Europe Ltd., based in London, England, and Sunovion
Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are
wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc.
Additional information can be found on the company’s websites: www.sunovion.com,
www.sunovion.eu
and www.sunovion.ca.
Connect with Sunovion on Twitter,
LinkedIn,
Facebook
and YouTube.

About Sumitomo Dainippon Pharma Co., Ltd.Sumitomo Dainippon
Pharma is among the top-ten listed pharmaceutical companies in Japan
operating globally in major pharmaceutical markets, including Japan, the
United States, China and the European Union. Sumitomo Dainippon Pharma
aims to create innovative pharmaceutical products in the Psychiatry &
Neurology area and the Oncology area, which have been designated as the
focus therapeutic areas. Sumitomo Dainippon Pharma is based on the
merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about
6,500 employees worldwide. Additional information about Sumitomo
Dainippon Pharma is available through its corporate website at www.ds-pharma.com.

LATUDA and SUNOVION are registered trademarks of Sumitomo Dainippon
Pharma Co., Ltd.BROVANA is a registered trademark of Sunovion
Pharmaceuticals Inc.APTIOM is a registered trademark of BIAL, used
under license.UTIBRON and SEEBRI are trademarks of Novartis AG,
used under license.NEOHALER is a registered trademark of Novartis
AG, used under license.